Simulations Plus Subsidiary DILIsym Awarded Grant for up to $1.7 Million For Model Development
July 23 2018 - 8:30AM
Business Wire
Novel in silico Drug-induced Kidney Injury
Model
DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP)
developing in silico modeling software, resources, and information
for assisting the pharmaceutical industry to more efficiently
develop safe and effective drug therapies, today announced it has
been awarded a Fast-Track Small Business Innovation Research (SBIR)
grant by the National Institutes of Diabetes and Digestive and
Kidney Diseases (NIDDK). The grant, coauthored by Dr. Brett Howell
(Principal Investigator) and Dr. Bud Nelson, is entitled “Software
for predicting a drug’s potential to cause acute kidney injury.”
The total award for this Fast Track SBIR grant is up to $1.7
million over the next 18-24 months. The initial award is for Phase
I, at a level of $225,000, with Phase II beginning in January 2019,
subject to successful completion of Phase I. Drug-induced kidney
injury can be costly, and may require multiple interventions,
including hospitalization. The goal of this project is to provide
software that can be used in drug development efforts to predict a
drug’s potential to cause drug-induced kidney injury, as well as
assess and improve the understanding of mechanisms of drug-induced
kidney injury.
Brett Howell, Ph.D., president of DILIsym Services, commented:
“We are thrilled to see that the NIH supports our mission to help
modernize drug development and reduce the time and costs associated
with developing new therapies. This large research grant will
provide the funding we need to produce the first version of
RENAsym™, which will be marketed to the pharmaceutical industry for
investigation and screening of possible drug-induced kidney damage.
Our team had already begun development of RENAsym, and we will now
ramp up to accelerate the process.”
Walt Woltosz, chairman of Simulations Plus, added: “This is a
major accomplishment by the DILIsym team, representing the largest
federal grant in Simulations Plus’ history. Building on our
expertise in drug-induced liver injury and nonalcoholic fatty liver
disease, RENAsym will expand our Quantitative Systems Pharmacology
(QSP) offerings to include potential damage to the kidney.
Identifying the potential for kidney damage as early as possible in
a drug development program can avoid costly failures later on in
expensive clinical trials. It’s worth noting that RENAsym, like
DILIsym® and NAFLDsym®, will require target tissue concentrations
generated by physiologically based pharmacokinetics (PBPK)
software, and the eventual tight integration of all three products
with our industry-leading GastroPlus™ PBPK platform will seamlessly
provide the required information to each program.”
About DILIsym Services, Inc.
DILIsym Services, Inc., was founded in 2015 in Research Triangle
Park, North Carolina, and is the leading provider of drug-induced
liver injury simulation software and related consulting services to
the pharmaceutical industry. The company spun out of the former
Hamner Institutes, acquiring all of the intellectual property,
software, documentation, and other materials for the DILIsym
software. The company’s other products include MITOsym® for
simulating in vitro mitochondrial function and a newer product
called NAFLDsym® for the study of nonalcoholic fatty liver disease
– a worldwide disease with few available treatment options.
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of drug discovery
and development software as well as a leading provider of both
preclinical and clinical pharmacometric consulting services for
regulatory submissions and quantitative systems
pharmacology/toxicology models for drug-induced liver injury and
nonalcoholic fatty liver disease. The company is a global leader
focused on improving the ways scientists use knowledge and data to
predict the properties and outcomes of pharmaceutical,
biotechnology, and chemical agents. Our software is licensed to and
used in the conduct of research by major pharmaceutical,
biotechnology, chemical, consumer goods companies, and regulatory
agencies worldwide. Our innovations in integrating new and existing
science in medicinal chemistry, computational chemistry, artificial
intelligence, pharmaceutical science, biology, and physiology into
our software have made us the leading software provider for
molecular property prediction from structure and physiologically
based pharmacokinetic modeling and simulation. For more
information, visit our website at www.simulations-plus.com.
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RelationsMs. Renee Bouche,
661-723-7723renee@simulations-plus.comorHayden IRMr. Cameron Donahue,
651-653-1854cameron@haydenir.com
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